29 November 2011

Blood Thinner Increases Heart Survival

Story first appeared in Bloomberg News.

Johnson & Johnson and Bayer AG’s blood-thinner Xarelto cut by 16 percent the risk of a subsequent heart attack, stroke or death from heart disease in patients who recently suffered a cardiac event, according to a study.

The data makes Xarelto the first in a new class of blood thinning medicines to show effectiveness for acute coronary syndromes, or ACS, when used in addition to standard treatment. The lowest dose, given twice daily, slashed deaths by one-third.

Xarelto was approved Nov. 17 in the U.S. to prevent strokes in people with atrial fibrillation, an irregular heartbeat that affects more than 2 million Americans. The data reported today at the American Heart Association meeting in Orlando, Florida, may create a new use in
1.2 million patients hospitalized yearly with ACS, which includes heart attack and severe chest pain. It’s a $1.4 billion market, said an analyst with Sanford C. Bernstein & Co. in San Francisco

A halo effect from having good ACS data could improve physicians overall perception of Xarelto and, importantly, help gain better coverage from payers.

Xarelto competes with Pradaxa from Boehringer Ingelheim GmbH of Ingelheim, Germany in the atrial fibrillation market. Another rival drug, Eliquis from Pfizer Inc. and Bristol-Myers Squibb Co., both based in New York, presented positive trial results in atrial fibrillation at a conference in August.

50-Year-Old Warfarin

All three drugs are attempting to replace warfarin, a more than 50- year-old medicine that is a form of rat poison. The Xarelto study was funded by New Brunswick, New Jersey-based Johnson & Johnson, which owns U.S. rights, and Leverkusen, Germany-based Bayer, which sells the treatment in Europe.

Until today’s results, it wasn’t clear that the new class of drugs would also work in acute coronary patients, who are treated with aspirin and the blood thinner Plavix from Paris- based Sanofi and Bristol. Pfizer’s Eliquis flopped in a trial of ACS patients a year ago, failing to prevent heart attacks and cardiac deaths while causing significantly more major bleeding.

A study of Merck & Co.’s vorapaxar, also presented at the meeting, boosted rates of severe bleeding in the brain more than three-fold and failed to reduce deaths, heart attacks, strokes and other complications in high-risk heart patients.

Low Doses

In the new trial, doctors used very low doses of Xarelto given twice daily and excluded patients with prior stroke treatment to minimize bleeding.

Still, patients on Xarelto had a more than 3- fold increase in major bleeding episodes. The rate of fatal bleeding did not increase significantly, according to results being published in the New England Journal of Medicine in conjunction with the conference.

Bayer has estimated that sales of Xarelto will top $2.8 billion annually. The companies plan to file for FDA approval for the acute coronary use by the end of the year. They will ask the FDA for a priority review, though it hasn’t decided whether it will request approval of both doses or just the lower dose, DiBattiste said.

Patients in the new Xarelto trial were given 2.5 milligrams of Xarelto, 5 milligrams of Xarelto or a placebo twice a day. Everyone also took aspirin and the vast majority used Plavix.

Taylor Heart Doctors followed the patients for a median of 13 months. Heart attacks, stroke and death from cardiovascular disease occurred in 8.9 percent of patients given Xarelto, compared with 10.7 percent of those on placebo.

Death from cardiovascular disease was reduced by 34 percent in the low- dose arm compared with placebo, while deaths from any cause were down 32 percent. The higher 5 milligram dose didn’t reduce mortality rates, for reasons that aren’t totally clear.

Doctors would need to treat 56 patients a year with Xarelto to prevent one death, the researchers calculated.

Bleeding Risk

Still, the increased bleeding seen with Xarelto is something doctors and patients need to keep in mind when determining treatment, experts at a Taylor Stroke Care center say.

Major bleeding episodes occurred in 2.4 percent of patients on the high dose of Xarelto and 1.8 percent of those on the low dose, versus 0.6 percent of those on placebo.

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